Abbott
Country not established FDA
Abbott is a medical device manufacturer, with 706 devices listed in 4 registries (FDA Class I, Class II, Unclassified and Class III) and 41 FDA recalls as of 12 Nov 2026.
- Devices
- 706
- Registrations
- FDA
- FDA recalls
- 4112 ongoing since 2021 (16 open in total)
Registry facts
- Registries
- FDA GUDID 692
- EUDAMED 229
- FDA 510(k) 13
- FDA PMA 1
- Device classes
- FDA Class I 393
- FDA Class II 280
- FDA Unclassified 8
- FDA Class III 1
- FDA recalls
- Identifiers
- DUNS 080174723
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Abbott makes
The company produces in vitro diagnostic (IVD) laboratory instruments and software, including analysers for spectrophotometry and chemiluminescent immunoassays, as well as related reagents and kits for testing hepatitis A, hepatitis B, and gamma-glutamyltransferase (GGT). It also manufactures single-use cardiac mapping catheters for percutaneous procedures and buffered sample diluents for diagnostic use, alongside glucose and carbon dioxide (CO₂) testing kits.
These products are regulated under Class I and Class II classifications in the US, with some devices exempt from classification (N). They are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
Search and filter all 706 devicesShowing 1-50 of 706
Company details
- DUNS number
- 080174723
- Phone
- +1(650)681-3470
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 3
- 2019 12
- 2020 7
- 2021 2
- 2022 4
- 2023 2
- 2024 2
- 2025 7
- 2026 1
2026
- 10 Sep 2026 Z-0191-2027 Not yet classified Ongoing Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
2025
- 10 Sep 2025 Z-0109-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 10 Sep 2025 Z-0110-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 10 Sep 2025 Z-0111-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 10 Sep 2025 Z-0112-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 10 Sep 2025 Z-0113-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 17 Mar 2025 Z-1643-2025 Class II Ongoing Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
- 17 Mar 2025 Z-1644-2025 Class II Ongoing Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
2024
- 4 Mar 2024 Z-1479-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
- 4 Mar 2024 Z-1480-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
Show the 25 most recent of 41 recalls
2023
- 28 Sep 2023 Z-0209-2024 Class II Ongoing Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
- 12 Jun 2023 Z-2110-2023 Class I Ongoing There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
2022
- 9 Jun 2022 Z-1344-2022 Class II Terminated When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
- 28 Apr 2022 Z-1213-2022 Class II Terminated Incorrect product labeling.
- 24 Mar 2022 Z-0956-2022 Class II Terminated Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Full distribution text
- 24 Mar 2022 Z-0957-2022 Class II Terminated Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Full distribution text
2021
- 16 Nov 2021 Z-0420-2022 Class II Terminated As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
- 9 Nov 2021 Z-0895-2022 Class II Terminated Instructions for use were updated.
2020
- 19 Jun 2020 Z-2701-2020 Class II Terminated Quality Control results were not properly evaluated for QC failures.
Full distribution text
- 22 May 2020 Z-2541-2020 Class II Terminated High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
- 12 May 2020 Z-2401-2020 Class II Terminated There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
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- 24 Apr 2020 Z-2117-2020 Class II Open since 2020 Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and
STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when
processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.
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- 9 Mar 2020 Z-1728-2020 Class II Terminated An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
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- 28 Feb 2020 Z-1700-2020 Class II Terminated Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
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- 24 Jan 2020 Z-1580-2020 Class II Terminated Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Full distribution text
- 19 Jun 2020 Z-2701-2020 Class II Terminated Quality Control results were not properly evaluated for QC failures.
FDA establishments
- ABBOTT GmbH Wiesbaden Hesse · DE FEI 3002809144
Frequently asked questions
How many devices does Abbott have in the registry?
The registry currently lists 706 devices for Abbott. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott's devices?
Among its 50 most recently registered devices, Abbott has devices listed in EUDAMED (12 devices), FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Abbott's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Abbott's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott?
FDA recall records list 41 recalls initiated by Abbott, the most recent initiated on 10 Sep 2026. 16 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Abbott in the registry?
The most recently registered devices listed for Abbott include Alinity 04T975A, Alinity 04T973A, Alinity 04T971A and AlinIQ 03R8968.
Which FDA establishments are linked to Abbott?
1 FDA establishment is linked to Abbott in the registry; they are listed on the company page.